Farnes Nadine, Stubhaug Audun, Hansson Per, Vambheim Sara M
Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Division of Emergencies and Critical Care, Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Division of Emergencies and Critical Care, Department of Pain Management and Research, Oslo University Hospital, Oslo, Norway.
Neuromodulation. 2024 Dec;27(8):1372-1382. doi: 10.1016/j.neurom.2024.09.002. Epub 2024 Nov 2.
This study aimed to investigate the analgesic effects of H-coil repetitive transcranial magnetic stimulation (rTMS) primarily targeting the hand area of the primary motor cortex (M1) in patients with peripheral neuropathic pain. Given that the H-coil has a wider reach than conventional coils, there is a possibility that targeting the hand motor cortex also may stimulate prefrontal areas. Thus, we also aimed to examine whether rTMS with an M1 target could produce effects on psychologic outcomes.
In total, 17 patients were randomly assigned to receive active or sham H-coil rTMS in a counterbalanced order. After a nine-week washout period, they crossed over to either active or sham rTMS, according to a double-blind crossover design. Each treatment period consisted of five daily rTMS sessions and a one- and three-week follow-up visit. The primary outcome was average usual pain intensity. Secondary outcomes included pain unpleasantness, dynamic and static mechanical allodynia, anxiety and depression, sleep, pain catastrophizing, function, and patients' impression of change. Effects of rTMS were investigated using linear mixed model analyses.
We found two significant interactions between treatment and time, indicating that active H-coil rTMS induced significant analgesic effects (t [134] = -2.18; p = .03; d = -0.10) and significant reductions in anxiety and depression compared with sham stimulation over the treatment course (t [73] = -2.14; p = .04; d = -0.09). The analgesic effect occurred two weeks after the treatment, and the effect on anxiety and depression occurred three weeks after treatment. No other significant interactions were found for the secondary variables.
Five days of H-coil rTMS targeting the hand area of M1 induced statistically significant effects on pain intensity. Moreover, rTMS improved symptoms of anxiety and depression, possibly because of the wide and deep reach of the H-coil.
The Clinicaltrials.gov registration number for the study is NCT05488808.
本研究旨在探讨主要针对原发性运动皮层（M1）手部区域进行H型线圈重复经颅磁刺激（rTMS）对周围神经性疼痛患者的镇痛效果。鉴于H型线圈的作用范围比传统线圈更广，针对手部运动皮层进行刺激有可能也会刺激前额叶区域。因此，我们还旨在研究以M1为靶点的rTMS是否会对心理结果产生影响。
总共17名患者按照平衡顺序被随机分配接受主动或假刺激H型线圈rTMS。经过为期9周的洗脱期后，根据双盲交叉设计，他们交叉接受主动或假刺激rTMS。每个治疗期包括每天进行5次rTMS治疗以及1周和3周后的随访。主要结局是平均日常疼痛强度。次要结局包括疼痛不适感、动态和静态机械性异常性疼痛、焦虑和抑郁、睡眠、疼痛灾难化、功能以及患者对变化的印象。使用线性混合模型分析来研究rTMS的效果。
我们发现治疗与时间之间存在两个显著的交互作用，表明主动H型线圈rTMS在整个治疗过程中诱导出显著的镇痛效果（t[134]=-2.18；p=.03；d=-0.10），并且与假刺激相比，焦虑和抑郁也有显著降低（t[73]=-2.14；p=.04；d=-0.09）。镇痛效果在治疗后两周出现，对焦虑和抑郁的影响在治疗后三周出现。次要变量未发现其他显著的交互作用。
针对M1手部区域进行5天的H型线圈rTMS对疼痛强度产生了具有统计学意义的影响。此外，rTMS改善了焦虑和抑郁症状，这可能是由于H型线圈作用范围广且深。
该研究在Clinicaltrials.gov上的注册号为NCT05488808。
